Thermal denervation devices and methods

ABSTRACT

A method and apparatus for treating an intraosseous nerve. The method includes positioning a hollow shaft through the cortical shell of a vertebral body and into a cancellous bone region of the vertebral body. The hollow shaft includes an annular wall having a longitudinal bore therein, a proximal portion and a distal portion, and a first window extending transversely through the annular wall. An electrosurgical probe is advanced within the longitudinal bore from the proximal portion toward the distal portion. The electrosurgical probe includes a first treatment element at a distal end of the probe, wherein the first treatment element being in electrical connection with a power supply. The first treatment element is slidably disposed within the longitudinal bore so that the first treatment element is advanced radially outward from the window and shaft to affect treatment of the intraosseous nerve within the cancellous bone region.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/845,699, filed Dec. 18, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/535,868, filed Nov. 7, 2014, now U.S. Pat. No.9,848,944, which is a divisional of U.S. patent application Ser. No.13/655,683, filed Oct. 19, 2012, now U.S. Pat. No. 8,882,764, which is acontinuation of U.S. patent application Ser. No. 12/643,997 filed Dec.21, 2009, which is a continuation of U.S. patent application Ser. No.11/745,446 filed on May 7, 2007, which is a continuation of U.S. patentapplication Ser. No. 10/401,854 filed on Mar. 28, 2003, now U.S. Pat.No. 7,258,690, each of which is incorporated herein by reference in itsentirety.

This application is also related to U.S. patent application Ser. No.10/259,689 filed on Sep. 30, 2002, now U.S. Pat. No. 7,326,203, which isincorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

In an effort to reduce back pain through early intervention techniques,some investigators have focused upon nerves contained within thevertebral bodies.

For example, PCT Patent Publication No. WO 01/0157655 (“Heggeness”)discloses ablating nerves contained within the vertebral body by firstboring into the vertebral body with a nerve ablation device, placing thetip of the device in close proximity to the nerve, and then ablating thenerves with the tip. Heggeness discloses numerous devices, such aselectricity transmitting probes, as candidate nerve ablation devices. Indescribing how to use such a probe, Heggeness discloses “raising thetemperature of tip 24 such that the intraosseous nerve is ablated by theheat generated by electrical current passing through tip.” See Heggenessat page 8, line 28. The probe disclosed by Heggeness appears to be asolid metal rod functioning as the active electrode of a monopolar RFdevice.

U.S. Pat. No. 6,478,793 (“Cosman”) discloses ablative treatment ofmetastatic bone tumors, including those within the spine. Pain relief isreportedly achieved by penetrating the bone wall with a suitable probe,and applying heat through the probe to ablate either the bone tumor orthe tissue near the bone tumor. Cosman teaches the use of both monopolarand bipolar probes in this application. See Cosman at col. 5, line 44.Cosman also teaches that the treatment may also be used to ablate thenerves and nerve ramifications in and/or around the bone to desensitizethem against further tumor encroachment. See Cosman at col. 8, lines50-65A, and col. 9, lines 9-17.

The only probes specifically disclosed by Cosman appear to be monopolar.However, monopolar approaches require the use of a grounding pad beneaththe patient and allows energy to flow from the probe and to dissipate inthe surrounding tissue. Because the path by which the energy flows froma monopolar probe to its corresponding pad is uncontrolled, the energymay undesirably flow through sensitive tissue, such as the spinal cord.Since this method may cause undesired local muscle or nerve stimulation,it may be difficult or dangerous to operate in sensitive areas of thehuman body.

Cosman teaches that the electrode may be rigid and robust and capable ofpiercing bone. Cosman teaches that the electrode may comprise a metaltubular shaft (with appropriate wall thickness to prevent buckling orbending during penetration of hard bone) with a rugged pointed tip. SeeCosman at col. 6, lines 34-46. Beyond teaching the use of a genericbipolar probe, Cosman does not disclose any particular bipolar electrodeconfiguration.

U.S. Pat. No. 6,168,593 (“Sharkey”) discloses thermal probes in whichthe electrodes are disposed at an angle to the longitudinal axis of theprobe. In one embodiment, an electrode is located in alaterally-disposed window of a tubular, electrically insulating shaft.See FIG. 1A. According to Sharkey, this electrode can ablate tissue atan angle to the principal axis of the probe.

Although the probe disclosed in FIG. 1A of Sharkey appears to bemonopolar, Sharkey also teaches that “bipolar delivery can beimplemented using the techniques of the current invention by providingat least two distinct elements on the tip, each connected to outgoingand return electrical paths from the RF power supply.”

Sharkey does not disclose a return and an active electrode locatedwithin the same window. Sharkey does not disclose a window in aconductive shaft. Sharkey does not disclose a probe having a tip adaptedto penetrate bone.

U.S. Pat. No. 5,944,715 (“Goble”) discloses electrosurgical instrumentswherein active electrodes 14 are housed within a window of an insulator.See FIGS. 1 and 4.

Like Sharkey, Goble does not disclose a return and an active electrodelocated within the same window, nor a window in a conductive shaft, nora probe having a tip adapted to penetrate bone.

SUMMARY OF THE INVENTION

The present inventors have found that the shaft of a bipolar probeadapted to penetrate bone can be made by simply joining a solid, sharptip onto a hollow tube. The resulting shaft is of sufficient strength topenetrate the cortical shell of a vertebral body. Furthermore, since theshaft comprises a hollow tube, wires for an electrode can be housedwithin the tube, thereby allowing a bipolar or sesquipolarconfiguration. The combination of the ability to penetrate a corticalshell and the ability to provide bipolar or sesquipolar functionrepresents an advance over the conventional technology.

Therefore, in accordance with the present invention, there is providedan electrosurgical device, comprising:

-   -   a) a hollow shaft having an annular wall having a longitudinal        bore therein, a proximal portion and a distal portion, and a        first window extending transversely through the annular wall,        and    -   b) a first electrode disposed within the window and being in        electrical connection with a power supply, and    -   c) a tip having a proximal end portion, a sharp tipped distal        end adapted to penetrate cortical bone, the proximal end portion        of the tip mechanically connected to the distal portion of the        bore of the hollow shaft.

In some embodiments, a space is provided between the tip and tube forease of manufacturing.

Also in accordance with the present invention, there is provided anelectrosurgical device, comprising:

-   -   a) a hollow shaft having an annular wall having a longitudinal        bore therein, a proximal portion and a distal portion, and    -   b) an electrically insulating spacer having a proximal end and a        distal end portion, the proximal end being mechanically        connected to the distal portion of the bore of the hollow shaft.

In another aspect of the present invention, the present inventors havefound that if the tubular portion of the shaft is made of anelectrically conductive material and a window is formed in that tubularportion, then a simple and effective probe can be made by electricallyinsulating the rim of the window and then placing an electrode withinthe insulated window. This configuration allows the construction of abipolar electrode having a simple and low cost design.

Therefore, in accordance with the present invention, there is providedan electrosurgical device, comprising:

-   -   a) a hollow shaft having an annular wall having a longitudinal        bore therein, a proximal portion and a distal portion, and a        first window extending transversely through the annular wall and        defining an inside rim, and    -   b) a first electrode disposed within the window and being in        electrical connection with a power supply, and c) an        electrically insulating material disposed between the inside rim        of the first window and the first electrode.

Also in accordance with the present invention, there is provided anelectrosurgical device, comprising:

-   -   a) a hollow shaft made of an electrically conductive material        having an annular wall having a longitudinal bore therein, a        proximal portion and a distal portion, and a first window        extending transversely through the annular wall, and    -   b) a first electrode disposed within the window and being in        electrical connection with a power supply.

In some embodiments, both the return and active electrodes are housedwithin the same window, thereby further reducing the complexity of themanufacturing process.

Therefore, in accordance with the present invention, there is providedan electrosurgical device, comprising:

-   -   a) a hollow shaft having an annular wall having a longitudinal        bore therein, a proximal portion and a distal portion, and a        first window extending transversely through the annular wall,        and    -   b) an active electrode disposed within the window and being in        electrical connection with a power supply, and    -   a return electrode disposed within the window and being in        electrical connection with the power supply.

DESCRIPTION OF THE FIGURES

FIG. 1 discloses a side view of a device of the present invention havinga pair of complementary electrodes housed within a window andelectrically isolated from the inside rim of the window by an insulatingmaterial.

FIG. 2 discloses a side view of a device of the present invention havinga single electrode housed within a window and electrically isolated fromthe inside rim of the window by an insulating material.

FIG. 3 discloses a side view of a device of the present invention havinga pair of electrodes traversing the diameter of the shaft and housedwithin opposing windows.

FIG. 4 discloses a side view of the present invention having a pluralityof electrodes housed within a plurality of windows.

FIG. 5a discloses a side view of a device of the present invention inwhich the device has been longitudinally cross-sectioned to revealnesting features.

FIG. 5b discloses an exploded view of FIG. 5 a.

FIG. 6 discloses a cross-sectional view of a device of the presentinvention having a grooved distal tip and a crimped shaft.

FIG. 7 discloses a cross-sectional view of a device of the presentinvention having a throughhole traversing the distal tip and shaft andfilled with a bonding material.

FIGS. 8a and 8b disclose distal tips of the present invention havingchamfered features.

FIGS. 9a-f disclose a circular transverse cross-sections of the sharptip.

FIG. 10 discloses a device of the present invention having a means fordelivering fluid that delivers fluid through an opening on the surfaceof the distal tip.

FIG. 11 discloses a device of the present invention having a means fordelivering fluid that delivers fluid through an opening on the surfaceof the insulating spacer.

FIG. 12a discloses a device of the present invention having a means fordelivering fluid that delivers fluid through a plurality of openings onthe surface of the insulating spacer.

FIG. 12b discloses a transverse cross section of FIG. 12a , takenthrough the spacer.

FIGS. 13a-b are cross-sections of devices of the present inventionhaving slidable temperature probes.

FIG. 13c is a cross-section depicting various preferred locations for atemperature probe of a device of the present invention.

FIGS. 14a-b are cross-sections of devices of the present inventionhaving multi-sensor temperature probes.

FIG. 15a is a cross-section of a device of the present invention havingradially segmented electrodes.

FIG. 15b is a side view of a device of the present invention havingaxially segmented electrodes.

FIG. 16 is a side view of a device of the present invention havingslidable electrodes.

FIG. 17 is a side view of a device of the present invention in whichboth the tip and shaft of the device are return electrodes.

FIGS. 18a and 18b present axial and transverse cross-sectional views ofan embodiment of the present invention in which the electrode surfacesare configured to allow current to flow out of only one side of thedevice.

FIGS. 19a and 19b present axial cross-sectional views of a telescopingembodiment of the present invention in which the electrodes are inrespective undeployed and deployed configurations.

DETAILED DESCRIPTION OF THE INVENTION

For the purposes of the present invention, the “resistive heating zone”is the zone of bone tissue that is resistively heated due to an energyloss incurred by current traveling directly through the bone tissue.Resistive heating, “joule” heating and “near-field” heating may be usedinterchangeably herein. The “conductive heating zone” is the zone ofbone tissue that is heated due to the conduction of heat from anadjacent resistive heating zone. The total heating zone (“THZ”) in abone tissue includes both the resistive heating zone and the conductiveheating zone. The border between the conductive and resistive heatingzones is defined by the locations where the strength of the electricfield is 10% of the maximum strength of the electric field between theelectrodes. For the purposes of the present invention, the heating zonesencompass the volume of bone tissue heated to at least 42° C. by thepresent invention. For the purposes of the present invention, the “firstand second sides” of a vertebral body are the lateral-lateral sidesintersected by the basivertebral nerve (“BVN”).

Preferably, the present invention comprises a novel probe adapted forpiercing cortical bone and having a novel bipolar electrodeconfiguration. More preferably, the present invention comprises a sharpstainless steel tip of sufficient sharpness to pierce cortical bone thatis welded to one end of a hollow stainless steel shaft (or, “hypotube”).More preferably, a slot or window is cut into the distal portion of theshaft, thereby providing a window into which insulated electrodes can beplaced. The insulation of the electrodes can be accomplished byproviding an insulating material, such as a plastic insert or a pottedencapsulant, between the inner rim of the window and the electrode.

This design is advantageous over conventional designs because itprovides a relatively inexpensive device that is sufficiently rigid andstrong to pierce cortical bone, thereby allowing its use for treatingosseous nerves and bone tumors within the bone.

In some embodiments, the outer metal shaft of the inventive probe can becoated with an electrical insulator, such as PTFE to electricallyinsulate the shaft from the body tissue.

In another embodiment of the present invention, there is provided aradiofrequency (RF) applicator device (or “probe”) comprising a hollowrigid tube (such as stainless steel) fitted with a handle at itsproximal end and an insulating spacer at its distal end, wherein aportion of the insulating spacer is nested within the distal end of thehollow tube. The proximal end of a distally disposed sharp tip is thennested through the spacer and into the distal end of the hollow tube,thereby imparting electrical isolation and greater strength to theassembled device. Preferably, the hollow tube is adapted to be a firstelectrode and the tip is adapted to be a second electrode, therebyforming a bipolar heating device adapted for treating hard tissue.Preferably, the device may optionally include channels or ports throughwhich a conductive fluid, such as saline, can be delivered to theheating zone to improve the efficiency of the device.

Now referring to FIG. 1, there is provided an electrosurgical device 1,comprising:

-   -   a) a hollow shaft 3 having an annular wall having a longitudinal        bore therein, a proximal portion 9 and a distal portion 11, and        a first window extending transversely through the annular wall        and forming a rim 15, and    -   b) an active electrode 21 disposed within the window and being        in electrical connection with a power supply via first lead 23,    -   c) a return electrode 31 disposed within the window and being in        electrical connection with the power supply via second lead 33,    -   d) an electrically insulating material 61 disposed between the        inside rim of the window and the first electrode,    -   e) a tip 51 having a solid proximal end 53 and a sharp tipped        distal end 55 adapted to penetrate cortical bone, the proximal        end of the tip being mechanically connected to the distal        portion of the bore of the hollow shaft,    -   f) an outer insulating shell 71 surrounding the proximal portion        of the hollow shaft,    -   g) a thermocouple 81 disposed within the electrically insulating        material and being in electrical connection with a digital        thermometer via third pair of leads 83.

The shaft of the present invention preferably comprises a hollow tubethat allows at least one lead wire to be run therethrough. The materialselection and dimensions of the shaft should be selected so as to allowthe shaft to support the penetration of the cortical bone by the tipwithout yielding. Typically, the shaft is made of a metallic or ceramicmaterial. Preferably, the shaft is made of a conductive material, suchas a metal. Preferably, the metallic shaft material is selected from thegroup consisting of stainless steel, titanium, titanium-containingalloys, such as nitinol, copper, and copper plated with gold orplatinum. More preferably, the metallic shaft material is stainlesssteel. In some embodiments, the shaft has a length of between 3 and 20cm (preferably between 5 cm and 12 cm, an inner diameter of between 0.5and 5 mm (preferably between 5 and 3 mm), and an outer diameter ofbetween 1 and 6 mm (preferably between 2.0 and 4 mm). When thedimensions of the shaft are within these ranges, conventionalbiomaterials such as stainless steel can be suitably used.

In some embodiments, the proximal end of the spacer is received over thedistal end of the shaft.

The function of the electrodes of the present invention is to be indirect contact with tissue and provide a pathway for RF current througha portion of the tissue surrounding the probe, thereby therapeuticallyheating the tissue. The electrodes are typically made of metals, such asstainless steel, platinum, gold, copper (nickel-plated or gold-plated),platinum, or a conductive polymer (such as a carbon- or silver-filledepoxy). Preferably, the electrode material of construction is such thatits coefficient of thermal expansion is within 50% of the coefficient ofthermal expansion of the material selected as the insulator 61.

The function of the insulating annulus of the present invention is toelectrically insulate the electrodes located within the window from theelectrically conductive shaft. The insulating annulus is typically madeof PTFE, nylon, an epoxy, a polyurethane, a polyimide, or other suitablepolymer, or a ceramic material.

Preferably, tip 51 provides two functions. First, its sharp tippeddistal end 55 should be sufficiently pointed to penetrate cortical bone.Accordingly, although angle α may be any angle between about 0 degreesand about 90 degrees, angle α is preferably between 20 and 70 degrees.When the tip angle is below this range, the tip may be fragile and maybe susceptible to breaking during cortical rim penetration. When theangle is above this range, the tip is too blunt and may requireexcessive force to achieve cortical rim penetration. In someembodiments, the proximal portion of the tip is solid, thereby providingadditional strength to the tip. In some embodiments, the proximalportion of the tip has a diameter that substantially the same as theouter diameter of the shaft. In this condition, the proximal portion ofthe tip may be mechanically joined to the distal end of the shaft (forexample, by welding) to produce a strong, streamlined probe.

In other embodiments, the sharp tipped distal end is formed near theaxial center of the tip to produce a conical shape.

In some embodiments, the device further comprises an outer insulatingsleeve (such as sleeve 71) surrounding at least the proximal portion ofthe hollow shaft. The function of the sleeve is to electrically isolatethe device from the tissue that is adjacent the target tissue, therebyincreasing the safety and effectiveness of the device. In someembodiments, the material of construction for the sleeve is selectedfrom the group consisting of polymeric materials such as PTFE andceramic materials such as alumina. In some embodiments, the sleeve isprovided in the form of a coating upon the shaft. In other embodiments,the sleeve is manufactured separately and slid over the shaft.Typically, the sleeve has a length that is between 50% and 95% of thelength of the shaft length. In some embodiments, the sleeve extendsdistally towards the window and terminates within one length of thewindow.

In some embodiments, the thermocouple is coupled to the power supply ina feedback loop to modulate the power output and thereby control thetemperature at the tip.

Now referring to FIG. 2, in other embodiments, the device of FIG. 1could be modified so that shaft window 213 houses only a singleelectrode 221. In this instance, the conductive shaft could beelectrically connected to the power supply via a handle (not shown) tobecome the second electrode 223 of a bipolar design. The advantage ofhaving only a single electrode within the window is that the area of thewindow can be decreased, thereby enhancing the strength of the shaft.When only a single electrode is located within the window, the surfacearea of that electrode is generally between 0.5 and 20 mm². This isadvantageous in applications requiring relatively larger surface areaelectrodes. In such embodiments, this embodiment can capably accommodatethe larger surface area electrode without increasing window area. Insome embodiments, the single windowed electrode could be the activeelectrode, while in others it could be the return electrode. In someembodiments, the single windowed electrode is the active and has asurface area of between 0.5 and 20 mm².

In this configuration, the placement of an insulating sleeve preferablyprovides a distal uninsulated portion of the shaft having a length ofbetween 3 mm and 20 mm, and is more preferably about 5 mm. In preferredembodiments thereof, the insulation is selected from the groupconsisting of polyimide tape, PTFE tape, and heat shrink tubing. Onepreferred thickness of the insulation ranges from about 0.006 mm toabout 0.012 mm) (i.e., about 0.00025 to 0.0005 inches), and is providedby a dielectric coating, such as a polyimide coating.

Now referring to FIG. 3, in other embodiments, the device of FIG. 1could be modified to include a pair of windows 313,315 located onopposite sides of the shaft. In such an embodiment, the electrodes321,323 and insulator 361 could be modified to essentially traverse thebore and connect the windows. This embodiment advantageously allows theclinician to treat target zones on either side of the device, and so isadvantageous in instances in which the device is placed within a targettissue such as a tumor.

Alternatively, in some embodiments, neither electrode completelytraverses the transverse width of the tube. In some embodiments thereof,each electrode opens through a window on the same side of the tube. Inother embodiments thereof, a first electrode opens through a firstwindow on a first side of the tube, and a second electrode opens througha second window on a second side of the tube, preferably on adiametrically opposed side of the tube.

Now referring to FIG. 4, in other embodiments, the device of FIG. 1could be modified to include a plurality of windows 413, 415, 417 spacedalong the length of the shaft, wherein each window has at least oneelectrode 423, 425, 427 located therein. Each of these windows iselectrically isolated from the conductive shaft by an insulating annulus461, 463, 465. The provision of multiple windowed electrodes allows thesurgeon the ability to either treat different zones at different timeswithout needing to move the device, or to treat a larger area. In someembodiments having a series of windows (not shown), both the return andactive electrodes can be located within the same window. In otherembodiments, each window houses a single (preferably, active) electrode,and the second (preferably, return) electrode 433,435,437 is provided onthe surface of the electrically conductive shaft between bands ofinsulating material. In other embodiments, the second return electrodeis provided by another windowed electrode. Thus, the surgeon can selectany pair of electrode to define the treatment area. In this particularembodiment, return electrode 433 is electrically connected to the powersupply via an internal lead (not shown) and is electrically isolatedfrom the remainder of the shaft by insulating windows comprising leftside portion 491 and right side portion 493.

In some embodiments, and now referring to FIGS. 5a and 5b , anintermediate spacer 591 is provided between the shaft 511 and the sharptip 521. When this spacer is made of an electrically insulatingmaterial, the sharp tip 521 could be adapted to function as the firstelectrode. In some embodiments thereof, the shaft 511 could be adaptedto function as the second electrode. The use of the tip and shaft aspaired electrodes is advantageous because of its simplicity of designand assembly, and its larger active surface area.

In some embodiments, as in FIGS. 5a and 5b , the insulating spacer ishollow. The hollow nature of the spacer allows a lead wire to runtherethrough and electrically connect the sharp tip to the power supply,and also allows the proximal end 523 of the tip to be nested in thehollow distal portion 595 of the spacer. In these FIGS. 5a and 5b , theproximal end portion 593 of the hollow spacer is nested within thedistal end portion 513 of the conductive shaft.

The robust nature of the embodiment shown in FIG. 5a could be furtherenhanced by proximally extending the nested portion of the hollow spacersufficiently deep into the distal portion of the shaft, therebyproviding increased surface area for bonding.

Similarly, the proximal end portion 523 of the sharp tip (the distalhalf 525 of which is preferably solid) can be made to extend so farproximally as to nest in the conductive shaft. Because the interveningspacer is made of an electrically insulating material, the conductivetip is electrically isolated from the conductive shaft. The proximalextension of the tip into the shaft likewise increases the robust natureof the probe.

Now referring to FIG. 6, the robust nature of the probe could be furtherfortified to prevent tip pull-out by providing a circumferential groove601 in the nested portion of the solid tip and providing a swage orcrimp 603 in the portion of the outer shaft overlying the groove. Insuch embodiments, the intervening insulating spacer should be made of amaterial sufficiently malleable to accept crimping or swaging.

Now referring to FIG. 7, the robust nature of the probe could be furtherfortified to prevent tip pull-out by providing a transverse through-hole701 through the probe in the area of the nested portion of the solid tipand then filling the throughhole with a bonding material such as anadhesive such as epoxy, or with an electrically non-conductive lockingpin or screw.

Now referring to FIG. 8a , in some embodiments, it may be desirable toprovide a tapered feature 801 upon the distal end of the sharp tip.Providing such a tapered feature is advantageous because a) it willprevent the device from penetrating through the anterior cortical wallof the vertebral body, and b) it will reduce current density at theelectrode tip and minimize regions of excessive current density, therebyproviding an even heating zone. In some embodiments, as in FIG. 8a , thetapered feature comprises a chamfer. In others, as in FIG. 8b , thetapered feature is more substantial and preferably comprises anessentially 180 degree rounded curve, such as a semicircle or a bulletnose 803.

Now referring to FIGS. 9a-9f , in some embodiments, the transverse crosssection of the sharp tip is acircular. The acircular cross-section mayallow the clinician to generate differently shaped heating profiles, orto access different anatomies (such as between tissue planes, or tofollow specific tissue contours (i.e., between the intervertebral discand spinal cord). In some preferred embodiments, the acircular crosssection is selected from the group consisting of rounded (as in FIG. 9a), oval (as in FIG. 9b ), elliptical (as in FIG. 9c ), bilobular (as inFIG. 9d ), arc-like (as in FIG. 9e ) and s-shaped (as in FIG. 9f ).

If the active electrode has no active cooling means, it may become besubject to conductive heating induced by the heated tissue, and theresultant increased temperature at the electrode-tissue interface in theelectrode may adversely affect performance by charring the adjacent bonetissue. Accordingly, in some embodiments, a cool tip active electrodemay be employed. The cooled electrode helps maintain the temperature ofthe electrode at a desired temperature. Cooled tip active electrodes areknown in the art. Alternatively, the power supply may be designed toprovided a pulsed energy input. It has been found that pulsing thecurrent favorably allows heat to dissipate from the electrode tip, andso the active electrode stays relatively cooler.

In some embodiments, and now referring to FIG. 10, it may also bedesirable to provide a means for delivering a fluid to the distal end ofthe device. The fluid may be a cooling fluid that will help control theheating activity, or it may be a carrier for therapeutic agents such asdrugs, or provide an electrolyte solution (such as isotonic orhypertonic saline) for efficient current flow. In some embodiments,providing the means for delivering a fluid could be accomplished byproviding a longitudinal fluid delivery tube 1001 extending from thetubular portion of the shaft to the outer surface 1003 of either thesharp tip 1005 or insulating spacer 1007. Preferably, the fluid deliverytube has a proximal portion 1011 extending into the tubular portion ofthe shaft and a distal portion 1013 opening onto the outer surface 1015of the sharp distal tip.

In some embodiments, as in FIG. 10, the fluid delivery tube is providedas a separate physical entity. In other embodiments, the fluid deliverytube is made by simply providing longitudinal, fluidly connected holesin the other components.

Now referring to FIG. 11, in some embodiments in which the sharp tip1113 also acts as an electrode, the fluid delivery tube 1101 has aproximal portion 1103 extending into the tubular portion 1105 of theshaft and a distal opening portion 1109 opening onto the outer surface1111 of the insulating spacer. In these embodiments, the spacer acts notonly as a conduit for fluid delivery, it still provides electricalinsulation between the sharp tip electrode and the shaft-basedelectrode. In some embodiments, as in FIG. 11, the fluid delivery tubecan comprise a separate physical entity portion 1115 and a portion 1117produced by making a hole in an already existing component (such asspacer 1121).

Now referring to FIG. 12a , in some embodiments, multiple fluid deliverytubes 1201, 1203 are used. In these embodiments, conductive efficiencyis enhanced because the multiple fluid delivery tubes may now deliverfluid all about the radius of the device, as shown in cross-sectionalFIG. 12b . FIG. 12b is a cross-section of FIG. 12 a taken transverselythrough the spacer. In FIG. 12b , longitudinal hole portions 1251 areprovided between the inner 1253 and outer 1255 diameters of the spacerto deliver fluid from within the shaft, while radially extending holeportions 1257 extend radially from the longitudinal hole portions anddeliver fluid to the outer surface 1259 of the spacer 1261.

In some embodiments, thermocouples are placed in radially extending holeportions of the fluid delivery tubes in order to monitor the surfacetemperature of the device at various radial locations. In theseembodiments, the fluid delivery tube having a thermocouple therein iseffectively blocked so that each tube has either a thermocouple or fluiddelivery function, but not both.

Also as shown in this embodiment, the proximal portion 1211 of eachfluid delivery tube can comprise a single inner wall 1213 and a singleouter wall 1215 defining a single large diameter annulus 1217therebetween. Fluid is delivered through this annulus to the proximalportion 1219 of the plurality of holes 1221 provided in the insulatingspacer.

The annular nature of the proximal portion of the fluid delivery tube isalso advantageous because it also provides a convenient inner tube 1223through which a lead 1225 can be run to electrically connect the sharptip 1227 to the power supply.

In general, it is desirable to operate the present invention in a mannerthat produces a peak temperature in the target tissue of between about80° C. and 100° C. When the peak temperature is below 80° C., theoff-peak temperatures may quickly fall below about 45° C. When the peaktemperature is above about 100° C., the bone tissue exposed to that peaktemperature may experience necrosis and charring. This charring reducesthe electrical conductivity of the charred tissue, thereby making itmore difficult to pass RF current through the target tissue beyond thechar and to resistively heat the target tissue beyond the char. In someembodiments, the peak temperature is preferably between 90° C. and 98°C.

It is desirable to heat the volume of target tissue to a minimumtemperature of at least 42° C. When the tissue experiences a temperatureabove 42° C., nerves within the target tissue may be desirably, damaged.However, it is believed that denervation is a function of the totalquantum of energy delivered to the target tissue, i.e., both exposuretemperature and exposure time determine the total dose of energydelivered. Accordingly, if the temperature of the target tissue reachesonly about 42° C., then it is believed that the exposure time of thevolume of target tissue to that temperature should be at least about 30minutes and preferably at least 60 minutes in order to deliver the doseof energy believed necessary to denervate the nerves within the targettissue.

Preferably, it is desirable to heat the volume of target tissue to aminimum temperature of at least 50° C. If the temperature of the targettissue reaches about 50° C., then it is believed that the exposure timeof the volume of target tissue to that temperature need only be in therange of about 2 minutes to 10 minutes to achieve denervation.

More preferably, it is desirable to heat the volume of target tissue toa minimum temperature of at least 60° C. If the temperature of thetarget tissue reaches about 60° C., then it is believed that theexposure time of the volume of target tissue to that temperature needonly be in the range of about 0.5 minutes to 3 minutes to achievedenervation, preferably 1 minute to 2 minutes.

Typically, the period of time that an intraosseous nerve (“ION”) isexposed to therapeutic temperatures is in general related to the lengthof time in which the electrodes are at the target temperature followingheat up. However, since it has been observed that the total heating zoneremains relatively hot even after power has been turned off (and theelectric field eliminated), the exposure time can include a period oftime in which current is not running through the electrodes.

In some embodiments, it is desirable to heat the target tissue so thatat least about 1 cm³ of bone tissue experiences the minimum temperature.This volume corresponds to a sphere having a radius of about 0.6 cm.Alternatively stated, it is desirable to heat the target tissue so theminimum temperature is achieved by every portion of the bone within 0.6cm of the point experiencing the peak temperature.

More preferably, it is desirable to heat the target tissue so that atleast about 3 cm³ of bone experiences the minimum temperature. Thisvolume corresponds to a sphere having a radius of about 1 cm.

In one preferred embodiment, the present invention provides asteady-state heated zone having a peak temperature of between 80° C. and100° C. (and preferably between 90° C. and 98° C.), and heats at least 1cm³ of bone (and preferably at least 3 cm³ of bone) to a temperature ofat least 50° C. (and preferably at least 60° C.).

As noted above, a peak temperature below about 100° C. is desirable inorder to prevent charring of the adjacent tissue, steam formation andtissue popping. In some embodiments, this is accomplished by providingthe power supply with a feedback means that allows the peak temperaturewithin the heating zone to be maintained at a desired targettemperature, such as 90-98° C. In some embodiments, between about 10watts and 30 watts of power is first supplied to the device in order torapidly heat the relatively cool bone, with maximum amperage beingobtained within about 10 15 seconds. As the bone is further heated tothe target temperature, the feedback means gradually reduces the powerinput to the device to between about 6 10 watts.

Although preferred embodiments of the present invention typicallycomprises bipolar electrodes, the probes of the present invention can beeasily adapted to provide monopolar use. For example, the device of FIG.2 could be modified so that the shaft is electrically isolated at thehandle, and a ground electrode is provided to extend from the powersupply to the patient.

The following section relates to the general structure of preferredenergy devices in accordance with the present invention:

The apparatus according to the present invention comprises anelectrosurgical probe having a shaft with a proximal end, a distal end,and at least one active electrode at or near the distal end. A connectoris provided at or near the proximal end of the shaft for electricallycoupling the active electrode to a high frequency voltage source. Insome embodiments, a return electrode coupled to the voltage source isspaced a sufficient distance from the active electrode to substantiallyavoid or minimize current shorting therebetween. The return electrodemay be provided integral with the shaft of the probe or it may beseparate from the shaft.

In preferred embodiments, the electrosurgical device will comprise ashaft or a handpiece having a proximal end and a distal end whichsupports one or more electrodes. The shaft may assume a wide variety ofconfigurations, with the primary purpose being to mechanically supportthe active electrode and permit the treating physician to manipulate theelectrode from a proximal end of the shaft. The shaft may be rigid orflexible, with flexible shafts optionally being combined with agenerally rigid external tube for mechanical support. Flexible shaftsmay be combined with pull wires, shape memory actuators, and other knownmechanisms for effecting selective deflection of the distal end of theshaft to facilitate positioning of the electrode array. The shaft mayinclude a plurality of wires or other conductive elements runningaxially therethrough to permit connection of the electrode array to aconnector at the proximal end of the shaft.

In some embodiments, the shaft comprises a hollow annulus adapted to beintroduced through a posterior percutaneous penetration in the patient.Thus, the shaft adapted for posterior percutaneous use may have a lengthin the range of about 3 to 25 cm (preferably, 12-15 cm), and a diameterin the range of about 1 mm to about 6 mm (preferably, 2-5 mm). However,for endoscopic procedures within the spine, the shaft will have asuitable diameter and length to allow the surgeon to reach the targetsite (e.g., a disc) by delivering the shaft through the thoracic cavity,the abdomen or the like. Thus, the shaft may have a length in the rangeof about 5.0 to 30.0 cm, and a diameter in the range of about 1 mm toabout 6 mm (preferably, about 2 mm to about 4 mm). In any of theseembodiments, the shaft may also be introduced through rigid or flexibleendoscopes.

The probe further comprises one or more active electrode(s) for applyingelectrical energy to the cancellous region of the vertebral body. Theprobe may be bipolar and include one or more return electrode(s). Insome embodiments thereof, the bipolar probe has an active electrodearray disposed at its distal end. In other embodiments, the probe may bemonopolar, whereby the return electrode may be positioned on thepatient's back, as a dispersive pad. In either embodiment, sufficientelectrical energy is applied through the probe to the activeelectrode(s) to heat the tissue in the target area and thereby denervateat least a portion of the basivertebral nerve within the vertebral body.

In some embodiments, the probe that is delivered percutaneously and/orendoluminally into the patient by insertion through a conventional orspecialized guide catheter. The catheter shaft may include a guide wirefor guiding the catheter to the target site, or the catheter maycomprise a steerable guide catheter. The catheter may also include asubstantially rigid distal end portion to increase the torque control ofthe distal end portion as the catheter is advanced further into thepatient's body.

In some embodiments, the electrically conductive wires may run freelyinside the catheter bore in an unconstrained made, or within multiplelumens within the catheter bore.

In some embodiments, the tip region of the device may comprise manyindependent electrode terminals designed to deliver electrical energy inthe vicinity of the tip. The selective application of electrical energyis achieved by connecting each individual electrode terminal and thereturn electrode to a power source having independently controlled orcurrent limited channels. The return electrode(s) may comprise a singletubular member of conductive material proximal to the electrode array.Alternatively, the instrument may comprise an array of return electrodesat the distal tip of the instrument (together with the activeelectrodes) to maintain the electric current at the tip. The applicationof high frequency voltage between the return electrode(s) and theelectrode array results in the generation of high electric fieldintensities at the distal tips of the electrode terminals withconduction of high frequency current from each individual electrodeterminal to the return electrode. The current flow from each individualelectrode terminal to the return electrode(s) is controlled by eitheractive or passive means, or a combination thereof, to deliver electricalenergy to the surrounding conductive fluid while minimizing energydelivery to surrounding (non-target) tissue.

In some embodiments, the device further comprises at least onetemperature probe. The temperature is preferably selected from the groupconsisting of a thermocouple, a thermistor, and a fiber-optic probe (andis preferably a thermocouple). Thermocouples associated with the devicemay preferably be disposed on or within the electrode carrier; betweenthe electrodes (preferred in bipolar embodiments); or within theelectrodes (preferred for monopolar embodiments). In some embodimentswherein the electrodes are placed on either side of the basivertebralnerve, a thermocouple is disposed between the electrodes or in theelectrodes. In alternate embodiments, the deployable portion of thethermocouple comprises a memory metal.

One common characteristic of conventional thermal therapy devices is thedimensionally fixed nature of the temperature probe. Because of thisfixed nature, the temperature probe can not be moved relative to theshaft, and so can not provide spatially-changing analysis unless theshaft is moved as well. Because it is often problematic to move theshaft, the fixed nature of the probe limits the extent of temperatureanalysis.

Now referring to FIG. 13a , in one aspect of the present invention,there is provided a thermal therapy device 1301 having a slidingtemperature probe. An axial bore 1303 is provided in the shaft 1306 ofthe present invention, and an elongate carrier 1305 having a probe 1307disposed thereon is placed within the bore for slidable movement withinthe bore. Because the carrier is slidable, the temperature probe may bemoved to different axial locations along the axis of the shaft by simplypushing or pulling the proximal end portion 1321 of the carrier, therebyproviding the clinician with the ability to easily measure temperatureat any selected axial location. In this particular instance, the distalend of the shaft has an opening 1311, thereby allowing the probe torecord temperatures outside of the shaft.

Therefore, in accordance with the present invention, there is provided athermal therapy device comprising:

-   -   a) a hollow shaft having an annular wall having an outer surface        and a longitudinal bore therein, the longitudinal bore being in        communication with an opening upon the outer surface,    -   b) a first electrode disposed on or within the shaft and being        in electrical connection with a power supply, and    -   c) a thermal probe having a elongate carrier and a thermal        sensor disposed on the carrier, wherein the carrier is slidably        disposed within the longitudinal bore.

Although the device of FIG. 13a is useful in providing temperatureinformation along the shaft axis, it can not provide off-axisinformation. Accordingly, in one preferred embodiment of the slidableprobe, and now referring to FIG. 13b , the carrier 1311 is made of amemory metal material. As before, an axial bore is provided in theproximal portion of the shaft. However, in this embodiment, while theproximal portion 1313 of the bore is linear, the distal portion 1315 ofthe bore curves to open onto the surface of the shaft through opening1317, thereby providing a curved bore. An elongate carrier 1311 made ofa memory metal having a probe 1319 disposed thereon is placed within thebore for slidable movement within the bore. Because the carrier is madeof a memory metal, the temperature probe may be moved to differentoff-axis locations by simply pushing or pulling the proximal end portion1321 of the carrier, thereby providing the clinician with an evengreater ability measure temperature radially around the device. In someembodiments, the temperature probe 1319 of FIG. 13b is located at theedge of the target zone to insure that the targeted zone is sufficientlydosed.

The temperature probe shown in FIG. 13a is located along the centralaxis of the shaft of the device. Although this central axial locationprovides ease of manufacture, the ability of the probe to record theactual tissue temperature may be diminished due to the fact that theprobe is not actually in the tissue, but rather in he center of thetherapeutic device.

Therefore, is some embodiments of the present invention, there isprovided a thermal therapy device 1331 having an axially-offsettemperature probe. Now referring to FIG. 13c , there are provided i) afirst temperature probe A located within the central axis of the shaft;ii) a second temperature probe B located within the outer wall of theshaft; iii) a third temperature probe C located on the outer surface ofthe wall of the shaft (i.e., at the wall/tissue interface); and iv) afourth temperature probe D located on the outer surface of the wall andat the electrode/insulator interface.

Locating the probe a position A allows the device to be easilymanufactured. Locating temperature probe B located within the outer wallof the shaft allows the device to be easily manufactured and durable,and avoids biocompatibility issues. Locating third temperature probe Cat the wall/tissue interface provides the most realistic estimate of thetissue temperature. Locating fourth temperature probe D at theelectrode/insulator interface allows the device to be easilymanufactured a provides measurement of a relatively hot region.

In general, bipolar and monopolar electrodes are used to apply a thermaltherapy to tissue for a therapeutic effect. Many probes are activelytemperature controlled to monitor and apply a certain thermal dose.Also, electrodes are often cooled (internally) to prevent charring nearor on the probe tip and thus allow more power to hear tissue furtheraway from the tip and to create a larger treatment zone. One majordrawback to this type of device is that the system is not able monitorthe temperature of the lesion. It only monitors the tip temperature,which is being cooled to 0° C., to allow more power to be put into thetissue and create a larger lesion.

In one embodiment of the present invention, and now referring to FIG.14a , there is provided a thermal therapy device 1401 having amulti-sensor temperature probe comprising a carrier 1403 and a pluralityof temperature sensors 1405, 1407 that deploys into the tissue tomonitor heating and thermal dose directly distal of the tip. In someembodiments, a sensor 1409 is also provided on the carrier to monitortemperatures in the vicinity of the electrodes 1411. In use, once thedevice is placed in the tissue, the linear multisensor temperature probeis deployed away from the surface of the probe. Preferably, adjacentmultisensors such as 1405 and 1407 are placed about 5 mm apart from eachother to give adequate data for temperature distribution within thetissue.

Now referring to FIG. 14b , there is provided a multisensor temperatureprobe as in FIG. 14a , but the carrier is made of a memory metal,thereby allowing the carrier to deploy from a side wall of the shaft andallowing the clinician to record off-axis temperature datasimultaneously from sensors 1415, 1417, 1419 and 1421 at a plurality ofdifferent locations.

The electrode terminal(s) are preferably supported within or by aninsulating support positioned near the distal end of the device. Thereturn electrode(s) may be located on the instrument shaft, on anotherinstrument, or on the external surface of the patient (i.e., adispersive pad). The return electrode is preferably integrated with theshaft. The proximal end of the shaft preferably includes the appropriateelectrical connections for coupling the return electrode(s) and theelectrode terminal(s) to a high frequency power supply, such as anelectrosurgical generator.

In some embodiments, the distal end of the device has surface geometriesshaped to promote the electric field intensity and associated currentdensity along the leading edges of the electrodes. Suitable surfacegeometries may be obtained by creating electrode shapes that includepreferential sharp edges, indented grooves, or by creating asperities orother surface roughness on the active surface(s) of the electrodes.Surface shapes according to the present invention can include the use offormed wire (e.g., by drawing round wire through a shaping die) to formelectrodes with a variety of cross-sectional shapes, such as square,rectangular, L or V shaped, or the like. Edges may also be created byremoving a portion of the elongate metal shaft to reshape thecross-section. For example, material can be ground along the length of around or hollow shaft electrode to form D or C shaped electrodes,respectively, with edges facing in the cutting direction. Alternatively,material can be removed at closely spaced intervals along the shaftlength to form transverse grooves, slots, threads or the like along theelectrodes. In other embodiments, the shaft can be sectored so that agiven circumference comprises an electrode region and an inactiveregion. In some embodiments, the inactive region is masked.

The return electrode is preferably spaced proximally from the activeelectrode(s) a suitable distance. In most of the embodiments describedherein, the distal edge of the exposed surface of the return electrodeis spaced about 2 to 25 mm from the proximal edge of the exposed surfaceof the active electrode(s). This distance may vary with differentvoltage ranges, the electrode geometry and depend on the proximity oftissue structures to active and return electrodes. The return electrodewill typically have an exposed length in the range of about 1 to 20 mm.Preferably, the ratio of the exposed length of the return electrode tothe active length of the active electrode is at least 2:1.

The present invention may use a single active electrode terminal or anarray of electrode terminals spaced around the distal surface of theshaft. In the latter embodiment, the electrode array usually includes aplurality of independently current-limited and/or power-controlledelectrode terminals to apply electrical energy selectively to the targettissue while limiting the unwanted application of electrical energy tothe surrounding tissue and environment resulting from power dissipationinto surrounding electrically conductive fluids, such as blood, normalsaline, and the like. The electrode terminals may be independentlycurrent-limited by isolating the terminals from each other andconnecting each terminal to a separate power source that is isolatedfrom the other electrode terminals. Alternatively, the electrodeterminals may be connected to each other at either the proximal ordistal ends of the shaft to form a single wire that couples to a powersource. Alternatively, different electrode terminals can be selected tobe active, thereby modifying the path of current and subsequent lesionsize and location.

In some embodiments, the plurality of active electrodes are radiallystaggered about the cross-section of the shaft. In some embodiments, theradially staggered electrodes are individually controllable.

Now referring to FIG. 15a , there is provided a transversecross-sectional view of a device of the present invention having apreferred active electrode configuration. This configuration alternatesthe active electrodes 1501, 1507, 1513, 1515 between insulating elements1505, 1511, 1509, 1503. The electrodes could be connected such that 1513was active and the grouping of 1515, 1507 and 1501 was connected to thereturn of the RF source. This would influence the heating pattern asshown in FIG. 15a . Other modes of operation would be to connect 1513 toactive and 1501 to return, or 1513 and 1501 to active and 1507 and 1515to ground. Any of several connections will allow for slight changes inthe heating pattern HP. In addition, the active electrodes could bemultiplexed in time such that 1513 and 1501 would be connected to activeand return, respectively for 1 to 10 seconds and then 1515 and 1507would be connected to active and return for 1 to 10 seconds. In thisway, the heating pattern can be manipulated to provide longer heatingtimes for selected combinations, thereby increasing the temperature ofthe targeted tissue. The electrodes could also be made operational in amonopolar fashion, such that an electrode (i.e., 1515 or 1501) would beactive for a period of time and then another electrode would be switchedon. Another embodiment would be to connect any combination of one, two,three or four electrodes to active and the return would be remote on thepatient. Any of these combinations could also be multiplexed in time orhave greater or lesser voltages to create more or less heating,respectively.

In some embodiments, the plurality of active electrodes are axiallysegmented along the axis of the shaft. Now referring to FIG. 15b , thereis provided a side view of a preferred active electrode configuration ofthe present invention. In this configuration, there is provided axiallyalternating active electrodes 1521, 1523 between insulating elements1525, 1527 and 1529. These elements could be activated by connecting1521 to active and 1523 to return, of the generator means. If 1521 wasof a larger surface area than 1523, more heating will occur around thesmall surface area electrode. In a monopolar setup, the electrodes couldbe operated separately whether by multiplexing each in time or byapplying the same or different voltages to each electrode.

In one configuration, each individual electrode terminal in theelectrode array is electrically insulated from all other electrodeterminals in the array within the shaft, and is connected to a powersource that is isolated from each of the other electrode terminals inthe array or to circuitry that limits or interrupts current flow to theelectrode terminal when a low resistivity material (e.g., blood) causesa lower impedance path between the return electrode and the individualelectrode terminal. The isolated power sources for each individualelectrode terminal may constitute separate power supply circuits havinginternal impedance characteristics that act to limit the supply of powerto the associated electrode terminal when a low impedance return path isencountered. By way of example, the isolated power source may be auser-selectable constant current source. In this embodiment, lowerimpedance paths will automatically result in lower resistive heatinglevels since the heating is proportional to the square of the operatingcurrent times the impedance. Alternatively, a single power source may beconnected to each of the electrode terminals through independentlyactuatable switches, or by independent current limiting elements, suchas inductors, capacitors, resistors and/or combinations thereof. Thecurrent limiting elements may be provided in the shaft, connectors,cable, controller or along the conductive path from the controller tothe distal tip of the device. Alternatively, resistance and/orcapacitance may be provided on the surface of the active electrodeterminal(s) by providing an oxide layer that forms selected electrodeterminals (e.g., titanium or a resistive coating on the surface ofmetal, such as platinum).

In a preferred aspect of the invention, the active electrode comprisesan electrode array having a plurality of electrically isolated electrodeterminals disposed over a contact surface (which may be a planar ornon-planar surface, and which may be located at the distal tip of thedevice or over a lateral surface of the shaft, or over both the tip andlateral surface(s)). The electrode array will include at least two andpreferably more electrode terminals, and may further comprise atemperature sensor. In a preferred aspect, each electrode terminal willbe connected to the proximal connector by an electrically isolatedconductor disposed within the shaft. The conductors permit independentelectrical coupling of the electrode terminals to a high frequency powersupply and control system with optional temperature monitoring of theoperation of the probe. The control system preferably incorporatesactive and/or passive current limiting structures, which are designed tolimit current flow when the associated electrode terminal is in contactwith a low resistance return path back to the return electrode.

The use of such electrode arrays in electrosurgical procedures isparticularly advantageous as it has been found to limit the depth oftissue necrosis without substantially reducing power delivery. Since theshaft is hollow, a conductive fluid could be added through the annulusof the shaft and flow into the bone structure for the purposes oflowering the electrical impedance and filling the spaces in thecancellous bone to make the target tissue a better conductor.

Another characteristic of conventional thermal-therapy electrode devicesis the dimensionally-fixed nature of the electrode. Because of thisfixed nature, the electrode can not be moved relative to the shaft, andso can not provide spatially-changing therapy unless the shaft is movedas well. Because it is often problematic to move the shaft, the fixednature of the electrode limits the extent of thermal therapy.

Now referring to FIG. 16, in one aspect of the present invention, thereis provided a thermal therapy device 1601 having a sliding electrode. Inone embodiment, the shaft 1602 comprises first 1603 and second 1605elongate portions having a reduced diameter. These reduced diameterportions are separated by an intermediate shaft portion 1607 of theshaft having a larger diameter. First 1611 and second 1613 annularelectrodes has bores dimensioned so as to be slidable within thosereduced diameter sections so that when the electrodes are placed uponthe reduced diameter sections, slidable movement within those reduceddiameter sections is obtained. Because the electrode is slidable, theelectrodes may be moved to different axial locations, thereby providingthe clinician with the ability to easily change the heating pattern atany selected axial location.

In some embodiments, each of the sliding electrodes is moved towardsintermediate portion 1607. This results in a smaller gap between theelectrodes and consequently a more compact heating pattern.

In some embodiments, each of the sliding electrodes is moved away fromintermediate portion 1607. This results in a larger gap between theelectrodes and consequently a more elongated heating pattern. If the gapis sufficiently large, then the heating pattern may form two essentiallyseparate zones adjacent to the electrodes.

In some embodiments, each of the sliding electrodes is moved in the samedirection (i.e., distally). This results in a more distal heatingpattern.

Therefore, in accordance with the present invention, there is provided athermal therapy device comprising:

-   -   a) a shaft having:        -   i) an first outer surface having first and second portions            having a first diameter, and        -   ii) a first reduced diameter outer surface located between            the first and second portions having the first diameter,    -   b) a first annular electrode disposed on the reduced diameter        outer surface of the shaft and dimensioned so as to be slidable        upon the reduced diameter outer surface, the electrode being in        electrical connection with a power supply.

Also in accordance with the present invention, there is provided athermal therapy device comprising:

-   -   a) a shaft having:        -   i) an first outer surface having first, second and third            portions having a first diameter, and        -   ii) first and second reduced diameter outer surface            portions, the first being located between the first and            second portions having the first diameter, and the second            being located between the second and third portions having            the first diameter,    -   b) a first and second annular electrodes disposed on the reduced        diameter outer surface of the shaft and dimensioned so as to be        slidable upon the respective first and second reduced diameter        outer surfaces, each electrode being in electrical connection        with a power supply so as to form and active and return        electrode.

It should be clearly understood that the invention is not limited toelectrically isolated electrode terminals, or even to a plurality ofelectrode terminals. For example, an array of active electrode terminalsmay be connected to a single lead that extends through the shaft to apower source of high frequency current. Alternatively, the device mayincorporate a single electrode extending directly through the shaft orconnected to a single lead that extends to the power source. The activeelectrode(s) may have a shape selected from the group consisting of aball shape, a twizzle shapes, a spring shape, a twisted metal shape, acone shape, an annular shape and a solid tube shape. Alternatively, theelectrode(s) may comprise a plurality of filaments, rigid or flexiblebrush electrode(s), side-effect brush electrode(s) on a lateral surfaceof the shaft, coiled electrode(s) or the like.

The current applied between the return electrode(s) and the electrodeterminal(s) is preferably a high or radio frequency current, typicallybetween about 50 kHz and 20 MHz, usually being between about 100 kHz and2.5 MHz, preferably being between about 400 kHz and 1000 kHz, often lessthan 600 kHz, and often between about 500 kHz and 600 kHz. The RMS (rootmean square) voltage applied will usually be in the range from about 5volts to 1000 volts, preferably being in the range from about 10 voltsto 200 volts, often between about 20 to 100 volts depending on theelectrode terminal size, the operating frequency and the operation modeof the particular procedure. Lower peak-to-peak voltages are preferredfor thermal heating of tissue, and will typically be in the range from100 to 1500, preferably 45 to 1000 and more preferably 45 to 80 voltsrms. As discussed above, the voltage is usually delivered continuouslywith a sufficiently high frequency RF current (e.g., on the order of 50kHz to 20 MHz) as compared with e.g., lasers that produce small depthsof necrosis and are generally pulsed about 10 to 20 Hz. In addition, thesine wave duty cycle (i.e., cumulative time in any one-second intervalthat energy is applied) is preferably on the order of about 100% for thepresent invention, as compared with pulsed lasers which typically have aduty cycle of about 0.0001%.

The power source allows the user to select the power level according tothe specific requirements of a particular procedure. The preferred powersource of the present invention delivers a high frequency currentselectable to generate average power levels ranging from severalmilliwatts to tens of watts per electrode, depending on the volume oftarget tissue being heated, and/or the maximum allowed temperatureselected for the device tip.

The power source may be current limited or otherwise controlled so thatundesired heating of the target tissue or surrounding (non-target)tissue does not occur. In one embodiment of the present invention,current limiting inductors are placed in series with each independentelectrode terminal, where the inductance of the inductor is in the rangeof 10 uH to 50,000 uH, depending on the electrical properties of thetarget tissue, the desired tissue heating rate and the operatingfrequency. Alternatively, capacitor-inductor (LC) circuit structures maybe employed, as described previously in U.S. Pat. No. 5,697,909.Additionally, current limiting resistors may be selected. Preferably,microprocessors are employed to monitor the measured current and controlthe output to limit the current.

The area of the tissue treatment surface can vary widely, and the tissuetreatment surface can assume a variety of geometries, with particularareas and geometries being selected for specific applications. Thegeometries can be planar, concave, convex, hemispherical, conical,linear “in-line” array or virtually any other regular or irregularshape. Most commonly, at least one of the active electrode(s) orelectrode terminal(s) will be formed at the distal tip of the device,and is frequently planar, disk-shaped, or hemispherical. Alternativelyor additionally, the active electrode(s) may be formed on lateralsurfaces of the electrosurgical instrument shaft (e.g., in the manner ofa spatula), facilitating access to certain body structures in endoscopicprocedures.

The devices of the present invention may be suitably used for insertioninto any hard or soft tissue in the human body, but are mostadvantageously used in hard tissue. In some embodiments, the hard tissueis bone. In other embodiments, the hard tissue is cartilage. Inpreferred embodiments when bone is selected as the tissue of choice, thebone is a vertebral body. Preferably, the present invention is adaptedto puncture the hard cortical shell of the bone and penetrate at least aportion of the underlying cancellous bone. In some embodiments, theprobe advances into the bone to a distance of at least ⅓ of thecross-section of the bone defined by the advance of the probe.

In some embodiments, there is provided a preferred procedure comprisinga first step of penetrating the hard cortical bone with a sharp tippedbiopsy needle housed in a cannula, and a second step of delivering adevice of the present invention having a radiused or bullet nose throughthe cannula through the location of pierced bone.

In some embodiments, the present invention is practiced in vertebralbodies substantially free of tumors. In others, the present invention ispracticed in vertebral bodies having tumors.

In some embodiments, the target region of the basivertebal nerve (BVN)is located within the cancellous portion of the bone (i.e., to theinterior of the outer cortical bone region), and proximal to thejunction of the BVN having a plurality of branches. Treatment in thisregion is advantageous because only a single portion of the BVN need beeffectively treated to denervate the entire system. In contrast,treatment of the BVN in locations more downstream than the junctionrequire the denervation of each branch.

In another embodiment, as in FIG. 17, the electrical connections betweenthe device and the power supply can be configured so as to cause each ofthe tip and the shaft to become return electrodes that sandwich anactive electrode.

In some embodiments of the present invention, the insulation and/orelectrode geometries are selected to provide a more directional flow ofcurrent out of the device. In some embodiments, the electrode portionsand insulating portions of the device are configured so that currentflows through a hemi-cylindrical portion of a transverse cross-sectionof the device. For example, in some embodiments, as shown in FIGS. 18aand 18b , there is provided a device comprising a shaft 1801, a spacer1803, and a tip 1805. The electrode portions 1807, 1809 and insulationportions 1811 of the device are configured so that current flows onlyacross a first side 1813 of the device.

Although the embodiment shown in FIGS. 18a and 18b describes an activeelectrode surface of about 180°, other variations in the arccircumscribed by the active electrode surface are also contemplated(such as about 90°, about 270°).

In other embodiments, the active electrode surface area may change alongthe longitudinal axis, thereby varying the heating profile. For example,the active electrode surface may taper from a proximal 180° arc to adistal 90° arc.

In some embodiments, there is provided a device having a telescopingdeployment of the electrodes. Now referring to FIGS. 19a and 19b , thereis provided a device of the present invention having insulating portions1901 and electrodes 1903, wherein the distal tip 1905 and the electrodes1903 are mounted on an inner shaft 1907 contained within a hollow outerhollow shaft 1909 in a concentric telescoping manner, such that thedistal tip and the electrodes of the inner shaft are deployable from thehollow outer shaft. FIG. 19a presents the device in an undeployedconfiguration, while FIG. 19b presents the device in a deployedconfiguration. In this embodiment, an electrode 1903 is located on thedistal tip 1905 of the inner shaft.

In some embodiments, the hollow outer shaft contains one or moreelectrodes 1904 located on or near the distal end 1911 of the hollowouter shaft.

In some embodiments, deployment of the electrodes is carried out by asimple sliding motion.

In others, the inner portion of the outer shaft and the outer portion ofthe inner shaft comprise complementary threadforms, so that the relativerotation of one of the shafts causes linear distal displacement of theinner shaft. The mechanical advantage provided by this embodimentprovides the clinician with an increased force and increased precision.

In another embodiment, the inner portion of the outer shaft and theouter portion of the inner shaft form a complementary pin-and-helicalgroove structure. This embodiment allows for a more rapid deployment ofthe electrodes to a fixed distal position.

Deployment mechanisms for these embodiments are well known in the artand are preferably located in part upon the proximal portion of a handleof the device.

This telescoping embodiment advantageously provides the surgeon with anability to adjust the location of an electrodes without moving theentire probe. That is, the surgeon may treat a first location, adjustthe location of the electrode by telescoping, and then treat a secondlocation.

Therefore, in accordance with the present invention, there is provided athermal therapy device comprising:

-   -   a) an outer shaft 1909 having i) a hollow bore 1921 defining an        inner surface 1923 and an distal opening 1925, and ii) a first        electrode 1904;    -   b) an inner shaft 1907 having i) an outer surface 1927        dimensioned so as to be axially movable within the bore of the        outer shaft and across the distal opening of the outer shaft,        and ii) a second electrode 1903,    -   wherein the first and second electrodes are in electrical        connection with a power supply to provide a voltage        therebetween.

EXAMPLE I

This prophetic example describes a preferred dual probe embodiment ofthe present invention.

First, after induction of an appropriate amount of a local anesthesia,the human patient is placed in a prone position on the table. The C-armof an X-ray apparatus is positioned so that the X-rays are perpendicularto the axis of the spine. This positioning provides a lateral view ofthe vertebral body, thereby allowing the surgeon to view the access ofthe apparatus into the vertebral body.

Next, the device of the present invention is inserted into the skin at alateral location so that its distal tip passes posterior to the dorsalnerves located outside the vertebral body.

Next, the device is advanced interiorly into the vertebral body so thatthe distal tip bores through the skin, into and through the corticalshell of the vertebral body. The device is advanced until the tipreaches the anterior-posterior midline of the vertebral body.

Next, the power supply is activated to provide a voltage between theactive and return electrodes. The amount of voltage across theelectrodes is sufficient to produce an electric current between theactive and return electrodes. This current provides resistive heating ofthe tissue disposed between the electrodes in an amount sufficient toraise the temperature of the local portion of the basivertebral nerve(BVN) to at least 45° C., thereby denervating the BVN.

What is claimed is:
 1. A method of treating an intraosseous nerve withina cancellous bone region of a vertebral body, comprising: positioning abipolar electrosurgical device through a cortical shell of a vertebralbody and into a cancellous bone region of the vertebral body, whereinsaid electrosurgical device comprises an elongate shaft with a distalelectrode on the elongate shaft and a proximal electrode spaced apartaxially from the distal electrode on the elongate shaft, the distal andproximal electrodes forming a bipolar heating device, wherein each ofthe proximal electrode and the distal electrode is exposed to anoutermost circumferential surface of the elongate shaft, wherein adistal edge of the proximal electrode is spaced between 2 mm and 25 mmfrom a proximal edge of the distal electrode, the elongate shaft furtherincluding a fluid delivery lumen extending therethrough, and a pluralityof temperature sensors positioned along a distal end portion of theelongate shaft, wherein at least one of the plurality of temperaturesensors is disposed between the proximal and distal electrodes; heatingan intraosseous nerve by applying a voltage between said distal andproximal electrodes to thereby heat at least a portion of the cancellousbone region of the vertebral body; and delivering a cooling fluid to thefluid delivery lumen to cool at least one of the distal and proximalelectrodes and maintain a temperature of the at least one of the distaland proximal electrodes at a desired temperature of less than 100° C.,wherein said heat is sufficient to denervate the intraosseous nervewithin the vertebral body.
 2. The method of claim 1, further comprising:using a thermocouple to monitor a temperature within a heating zoneproduced by the bipolar heating device; and maintaining the temperaturewithin the heating zone within a desired temperature range.
 3. Themethod of claim 1, further comprising using a thermocouple on thebipolar electrosurgical device to monitor a temperature within a heatingzone produced by the bipolar heating device.
 4. The method of claim 3,further comprising maintaining the temperature within the heating zonewithin a desired temperature range.
 5. The method of claim 4, whereinmaintaining the temperature within the heating zone within a desiredtemperature range comprise reducing a power input to the bipolarelectrosurgical device.
 6. The method of claim 1, wherein at least oneof the temperature sensors of the bipolar electrosurgical deviceincludes a thermocouple.
 7. The method of claim 6, wherein thethermocouple extends through the fluid delivery lumen of the bipolarelectrosurgical device.
 8. The method of claim 6, wherein thethermocouple extends through an axial bore provided in the elongateshaft.
 9. The method of claim 1, comprising modulating power to thebipolar electrosurgical device to control a temperature at the distalend of the elongate shaft.
 10. A method of treating a vertebral body,comprising: positioning a bipolar electrosurgical device through acortical shell of a vertebral body and into a cancellous bone region ofthe vertebral body, wherein said electrosurgical device comprises anelongate shaft with a distal electrode on the elongate shaft and aproximal electrode spaced apart axially from the distal electrode on theelongate shaft by electrically insulating material, wherein a distaledge of the proximal electrode is spaced between 2 mm and 25 mm from aproximal edge of the distal electrode, the distal and proximalelectrodes forming a bipolar heating device, wherein each of theproximal electrode and the distal electrode is exposed to an outermostcircumferential surface of the elongate shaft, the elongate shaftfurther including a fluid delivery lumen extending therethrough, and atleast one temperature sensor disposed along the distal end portion ofthe elongate shaft to monitor temperature of the device at variouslocations; heating an intraosseous nerve by applying a voltage betweensaid distal and proximal electrodes to thereby heat at least a portionof the cancellous bone region of the vertebral body; and delivering acooling fluid to the fluid delivery lumen to cool at least one of thedistal and proximal electrodes, wherein said heat is sufficient to treatthe vertebral body.
 11. The method of claim 10, further comprising:using a thermocouple to monitor a temperature within a heating zoneproduced by the bipolar heating device; and maintaining the temperaturewithin the heating zone within a desired temperature range, and whereinthe vertebral body includes a tumor.
 12. The method of claim 10, whereinthe vertebral body includes at least one tumor.
 13. The method of claim12, wherein the heat is sufficient to treat the at least one tumor. 14.The method of claim 10, further comprising using a thermocouple of theat least one temperature sensor to monitor a temperature within aheating zone produced by the bipolar heating device.
 15. The method ofclaim 14, further comprising maintaining the temperature within theheating zone within a desired temperature range.
 16. The method of claim15, wherein maintaining the temperature within the heating zone within adesired temperature range comprise reducing a power input to the bipolarelectrosurgical device.
 17. The method of claim 10, wherein the at leastone temperature sensor of the bipolar electrosurgical device includes athermocouple.
 18. The method of claim 17, wherein the thermocoupleextends through the fluid delivery lumen of the bipolar electrosurgicaldevice.
 19. The method of claim 18, wherein the thermocouple extendsthrough an axial bore provided in the elongate shaft.
 20. The method ofclaim 10, further comprising modulating power to the bipolarelectrosurgical device to control a temperature at the distal end of theelongate shaft.